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Rockwell Medical(RMTI) - 2020 Q4 - Earnings Call Transcript
2021-04-01 02:09
Rockwell Medical, Inc. (NASDAQ:RMTI) Q4 2020 Earnings Conference Call March 31, 2021 4:30 PM ET Company Participants Claudia Styslinger - IR, Argo Partners Russell Ellison - President and CEO Tim Chole - VP, Marketing Marc Hoffman - CMO Russell Skibsted - EVP, CFO and Chief Business Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Operator Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Fourth Quarter and Full Year 2020 Results Call. At this time all particip ...
Rockwell Medical(RMTI) - 2020 Q4 - Annual Report
2021-03-31 21:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-23661 ROCKWELL MEDICAL, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...
Rockwell Medical (RMTI) Investor Presentation - Slideshow
2021-03-12 19:28
® ROCKWELL | --- | --- | --- | --- | --- | |---------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | ROCKWELL MEDICAL, INC. | | | | | | TRANSFORMING IRON DEFICIENCY AND ANEMIA MANAGEMENT March 2021 | | | | | FORWARD-LOOKING STATEMENTS 2 Certain statements in this presentation may constitute "forward-looking statements" within the meaning of federal securities laws, including, but not limited to, Rockwell Medical's intention to commercialize Triferic® Dia ...
Rockwell Medical(RMTI) - 2020 Q3 - Earnings Call Transcript
2020-11-10 01:49
Financial Data and Key Metrics Changes - The company ended the third quarter with cash, cash equivalents, and investments of more than $67 million, with cash used in operating activities for the nine months ended September 30 being approximately $21 million, comparable to the same period last year [58] - Net sales for the third quarter were $15.3 million, which is comparable to the same period last year, with Triferic net sales for the three months ended September 30, 2020, being approximately $284,000 [59] - The net loss for the third quarter improved to approximately $7.4 million from $7.9 million in the third quarter of last year, driven primarily by reductions in both commercial and G&A spending [61] Business Line Data and Key Metrics Changes - The number of contracted patients for Triferic increased to approximately 3,400, translating to an annualized treatment volume of approximately 500,000, a meaningful increase compared to the last quarter [35] - The overall growth in Triferic sales was lower than expected due to restrictions on in-person visits to dialysis clinics, but virtual engagement tactics helped maintain progress [36][70] Market Data and Key Metrics Changes - The company is focused on expanding its global commercial reach, with significant progress in international partnerships, including in China, India, and South Korea [53][54][56] - The home infusion therapy market is rapidly growing, with over 3.2 million patients served annually, and an estimated 60% incidence of iron deficiency anemia in this patient population [23] Company Strategy and Development Direction - The company aims to maximize U.S. sales of Triferic Dialysate and the soon-to-be-launched Triferic AVNU, while also expanding global commercial reach and developing new indications for its FPC platform [19][63] - The top priority for new indications is FPC for treating iron deficiency anemia in patients undergoing home infusion therapy, with plans to submit a clinical development plan to the FDA [22][66] Management Comments on Operating Environment and Future Outlook - Management acknowledged the ongoing challenges posed by the COVID-19 pandemic, which has impacted the dialysis industry and restricted access to clinics [30][33] - The company expects to see a reacceleration of adoption of Triferic once the pandemic begins to resolve, and is making final preparations for the commercial launch of Triferic AVNU [64] Other Important Information - The company has a solid core business generating over $60 million annually, with one branded product in the market and a second one about to be launched [15] - The company has entered into partnerships for the commercialization of Triferic in key international markets, which are expected to generate significant growth over time [16][56] Q&A Session Summary Question: Can you talk about any gating factors that are still required or needed to get through before the launch of Triferic AVNU? - The delay was minor and related to scheduling of the production of packaging, with no further manufacturing issues anticipated [77] Question: Can you provide any color on the gross margin in the quarter? - The improvement in gross margin was primarily due to product mix, with ongoing efforts to make processes more efficient and cost-effective [79] Question: How long is Wanbang expected to take to reach full enrollment in the pivotal Triferic trial in China? - Full enrollment is anticipated in the first half of 2023, depending on the speed of enrollment [83] Question: What is the status of the regulatory review in India? - There is no firm answer on when the suspension of regulatory review will be lifted, as it is related to the incidence rate of COVID-19 cases [84] Question: What is the status of the evaluation programs for Triferic AVNU? - The first evaluation programs started in early October, and it is too early to report comprehensive results [86]
Rockwell Medical(RMTI) - 2020 Q2 - Earnings Call Transcript
2020-11-09 23:16
Rockwell Medical, Inc. (NASDAQ:RMTI) Q2 2020 Earnings Conference Call November 9, 2020 4:20 PM ET Company Participants Claudia Styslinger – Investor Relations Russell Ellison - President, Chief Executive Officer & Director Tim Chole – Vice President, Marketing Russell Skibsted - Executive Vice President, Chief Financial Officer & Chief Business Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Blair Cohen - H.C. Wainwright & Co. Disclaimer: *NEW* We are providing this transcript ...
Rockwell Medical(RMTI) - 2020 Q3 - Earnings Call Presentation
2020-11-09 21:45
| --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|------------------------------------------------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | Q3 2020 FINANCIAL RESULTS AND BUSINESS UPDATE | | | | | | | | CALL PARTICIPANTS | --- | --- | |---------------------------------------|-------------------------------------------------| | Russell Ellison, M.D., M.Sc. | President and Chief Executive Officer | | Russell Skibsted | Chief Financial Officer, Chief Busine ...
Rockwell Medical(RMTI) - 2020 Q1 - Earnings Call Transcript
2020-05-12 01:54
Rockwell Medical, Inc. (NASDAQ:RMTI) Q1 2020 Earnings Conference Call May 11, 2020 4:30 PM ET Company Participants Claudia Styslinger - Assistant Vice President at Argot Partners, LLC Russell Ellison - President and Chief Executive Officer Marc Hoffman - Chief Medical Officer Tim Chole - Vice President of Marketing Angus Smith - Chief Financial Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald L.P. Blair Cohen - HC Wainwright Operator Good afternoon, ladies and gentlemen, and thank you ...
Rockwell Medical(RMTI) - 2019 Q4 - Earnings Call Transcript
2020-03-13 03:09
Financial Data and Key Metrics Changes - Net sales for Q4 2019 were $15.5 million, a decrease from $16.9 million in Q4 2018 [23] - Net sales of hemodialysis concentrates were $15.3 million in Q4 2019, down from $16.8 million in Q4 2018, primarily due to a decrease in international concentrate sales [23] - Net sales of Triferic were approximately $2.28 million in Q4 2019, significantly up from $68,000 in Q4 2018 [24] - Operating loss improved to $7.4 million in Q4 2019 from $9.4 million in Q4 2018, attributed to reduced G&A expenditures [27] - Net loss for Q4 2019 was $7.3 million or $0.11 per share, compared to a net loss of $9.4 million or $0.17 per share in Q4 2018 [30] Business Line Data and Key Metrics Changes - The company entered into 10 additional contracts during Q4 2019, representing a 77% increase in clinics under contract compared to Q3 2019 [11] - More than 80% of customers were on Triferic on an ongoing basis, indicating strong market traction [11] Market Data and Key Metrics Changes - The company reported a 67% increase in the number of annualized treatments under contract from Q3 to Q4 2019, equating to an increase of 100,000 annualized treatments [11] - The market opportunity for Triferic in hemodialysis is potentially in excess of $1 billion globally [18] Company Strategy and Development Direction - The company aims to transform anemia management in ESRD patients and expand into other therapeutic indications over the next 3 to 5 years [7] - The launch of Dialysate Triferic in the U.S. and the anticipated approval of IV Triferic are key components of the company's strategy [22] - The company is also exploring partnerships for Triferic's commercialization in international markets, including India and China [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming PDUFA date for IV Triferic and the potential for expanding Triferic adoption both domestically and internationally [12][14] - The company expects to see continued acceleration of adoption of Dialysate Triferic in 2020, supported by successful evaluation programs [10] Other Important Information - The company has expanded its medical advisory board with renowned nephrologists to enhance its medical capabilities [16] - The real-world data program has grown to include 8 clinics with over 700 patients, with plans to double the number of clinics in early 2020 [17] Q&A Session Summary Question: How many of the 160 clinics do you anticipate using Triferic by the end of this year? - Management indicated that while specific numbers were not provided, they expect to significantly accelerate the pace of adoption through MDOs [36] Question: Any recent requests from FDA regarding MDA for IV Triferic? - Management confirmed normal correspondence with the FDA ahead of the PDUFA date and expressed excitement about the upcoming decision [38] Question: Timeline updates for regulatory approvals in Chile? - Management expects to have approval in Chile later this year after delays due to civil unrest [39] Question: Status of the FDA untitled letter regarding the website? - Management stated that they have removed certain references from the website and are in dialogue with the FDA to resolve the matter [39]
Rockwell Medical (RMTI) Investor Presentation - Slideshow
2020-02-11 17:11
Triferic Overview - Rockwell Medical is a commercial-stage company focused on transforming anemia management, initially targeting ESRD[7] - Triferic is designed to replace iron and maintain hemoglobin without increasing ferritin levels[7] - The global Triferic market potential is estimated to exceed $1 billion[7] Triferic Clinical and Commercial Progress - Dialysate Triferic was launched in the U S in May 2019[10] - An NDA for I V Triferic was submitted in May 2019, with a PDUFA date of March 28, 2020[10, 13] - Clinical data is being collected from seven sites with over 500 patients, with initial data expected in Q1 2020[12] - Clinics adopting Triferic have shown a 75% conversion rate since launch[18] Market and Financial Position - Rockwell Medical generates over $60 million in annual revenue from dialysis concentrates[7] - The U S market for anemia management therapies in CKD is over $4 1 billion annually[40] - The company is the 2 supplier of dialysis concentrates in the U S [7] International Expansion - Partnerships are in place for Triferic in China, India, Canada, Peru, and Chile[11] - The estimated peak market opportunity in China is over $400 million[52] - The estimated peak market opportunity in Europe and Japan is over $600 million[53]
Rockwell Medical(RMTI) - 2019 Q3 - Earnings Call Transcript
2019-11-12 03:38
Rockwell Medical, Inc. (NASDAQ:RMTI) Q3 2019 Results Conference Call November 11, 2019 4:30 PM ET Company Participants Judy DiClemente - In-Site Communications, Investor Relations Stuart Paul - President and Chief Executive Officer Angus Smith - Chief Financial Officer John McLaughlin - Chairman Conference Call Participants Brandon Folkes - Cantor Fitzgerald Chris Raymond - Piper Jaffray Edward Marks - H.C. Wainwright Operator Good day, ladies and gentlemen. And welcome to the Rockwell Medical 2019 Q3 Resul ...